CONCENTRIC BALLOON GOOGLE— 510(k) K112698

Name: FDA 510(k) clearance K112698
Creator: U.S. Food and Drug Administration
Published: 2012-05-18

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K112698 for CONCENTRIC BALLOON GOOGLE, Substantially Equivalent on 2012-05-18. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-09-16
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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